Machinery Regulation FAQ Notified Bodies

Start with Annex I. Part A covers categories that must use one of the third-party routes in Article 25(2): EU type-examination followed by conformity to type, full quality assurance, or unit verification. Those routes involve a notified body.

Part B gives manufacturers more room, but not always a self-assessment route. Article 25(3) allows internal production control only when the machinery or related product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. If that coverage is missing or only partial, the manufacturer must use EU type-examination, full quality assurance, or unit verification.

If the product is not listed in Annex I, Article 25(4) points to internal production control. A notified body may still be useful commercially or technically, but the Regulation route itself is not the reason unless another applicable EU act requires it.

Use the EU Single Market Compliance Space notified-bodies search by legislation. Select Regulation (EU) 2023/1230 on machinery, then check bodies notified for the legislation and the relevant conformity-assessment activity before approaching one.

Do not treat a general certificate, test lab report, or consultant statement as a notified-body approval. The body should be notified for the machinery legislation and the assessment route you need, and its identification number should match the body named in the certificate, quality-system decision, unit-verification certificate, or EU declaration entry.

Keep a dated lookup record because notification scope can change. If a notified body is suspended, restricted, withdrawn, or ceases activity, the Regulation assigns follow-up handling to notifying authorities, but the manufacturer still needs a usable conformity record for the product.

Under Module B, the notified body examines the technical design, reviews technical documentation, checks representative specimens where required, and issues or refuses an EU type-examination certificate. The manufacturer then uses Module C to keep production in conformity with the approved type.

Under Module H, the notified body assesses the manufacturer's quality system, including design controls, product quality responsibilities, examinations, tests, records, and monitoring. It also performs surveillance through audits and may make unexpected visits.

Under Module G, the notified body examines and tests the individual machinery or related product, or has tests carried out, and issues a certificate for the examinations and tests performed. This is not a blanket approval for future variants.

A notified-body certificate is not the whole compliance file. The manufacturer must still demonstrate that the product meets the applicable essential health and safety requirements in Annex III, draw up technical documentation, issue the EU declaration of conformity, affix the CE marking, and keep required records available for market surveillance.

Technical documentation should show the intended use, risk assessment, applicable EHSRs, protective measures, residual risks, drawings, standards or common specifications applied, other technical specifications used for uncovered requirements, test and inspection results, and production controls.

Changes matter after the first assessment. The manufacturer must account for changes in design, production, characteristics, harmonised standards, technical specifications, or common specifications. For Module B, modifications affecting conformity or certificate validity require additional notified-body approval.